Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03471858
Eligibility Criteria:
Inclusion Criteria:
* Female ≥ 21 years of age at booking visit
* 1 previous uncomplicated lower segment caesarean section (CS)
* Aiming for TOLAC
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
* Singleton pregnancy
* Gestational age \>37 weeks
* Understands risk of TOLAC
* Eligible for induction of labour for the standard obstetric indications, including post-date or post-term pregnancies at 40-41 completed weeks of gestation
* Unfavourable Bishop's Score ≤ 5 requiring cervical priming
* Previous uterine surgery, including simple myomectomy, where there is no contraindication to TOLAC
* Reactive CTG pre-induction
* Ruptured membranes
Exclusion Criteria:
* Refusal to participate
* Women with 2 or more previous CS
* Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery
* Previous uterine surgery with contra-indication to future TOLAC
* Maternal contraindication for vaginal delivery
* Fetal contraindication for vaginal delivery or major fetal abnormality
* Malpresentation or cord presentation
* Placenta praevia \<20mm from internal os
* Chorioamnionitis
* Antepartum haemorrhage of undetermined origin AND deemed a contraindication for TOLAC
* Suspected fetal macrosomia (estimated weight on ultrasound \>4kg) AND deemed a contraindication for TOLAC
* Congenital uterine abnormality
* Multifetal pregnancy
* Latex allergy or poorly-controlled asthma
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03471858
Study Brief:
Protocol Section:
NCT03471858